Paxil (paroxetine) has been available with FDA approval to patients suffering symptoms of depression since 1992. However, in 2005, researchers reported that Paxil could create a risk for birth defects. Their research indicated that a woman who took Paxil during the first trimester of her pregnancy had a greater chance of giving birth to a child with defects to the heart and other organs.
The FDA cites two studies on these effects in a press release. One study found that the risk of this defect doubled among women taking Paxil. The government then asked the manufacturer of the drug, GlaxoSmithKline, to increase its warning to potentially pregnant women about this risk. A study published later – in the New England Journal of Medicine in 2007– linked Paxil and other medications in its category (SSRIs, or selective serotonin reuptake inhibitor antidepressants) to additional birth injury risks, including neural tube defects such as spina bifida and anencephaly.
What about women who took Paxil or other SSRIs at this time or earlier and who had children with birth defects? Are drug manufacturers responsible for the costs related to children’s birth injuries? The answer is yes, if the following can be established in a lawsuit:
An injury indeed occurred
The medication led to or contributed to the injury
The injury created costs for the family or the patient
It is important to note the statute of limitations in California cases allows plaintiffs in product liability lawsuits to wait to file until the child turns 18 years old, plus up to three years after that. This allows for the discovery of an injury and its effect on the child’s life. Be aware, however, that with medical malpractice, such as when a physician makes a mistake, the statute of limitations is more stringent.
Posted in Product Liability
Tagged defective drugs, paxil, SSRI